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Positron Emission Tomography/Computerized Tomography (PET/CT) Guided Fulvestrant Therapy for Patients With Recurrent or Metastatic Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by British Columbia Cancer Agency.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
British Columbia Cancer Agency
ClinicalTrials.gov Identifier:
NCT00816582
First received: December 30, 2008
Last updated: September 2, 2010
Last verified: September 2010
  Purpose

Purpose:

To determine whether [18F]FES can predict clinical benefit (defined as complete response, partial response and stable disease ≥ 6 months) to fulvestrant (250 mg IM q 28 days) in post-menopausal women with recurrent or metastatic ER+ breast cancer who are candidates for further hormonal therapy.


Condition Intervention Phase
Breast Cancer
Procedure: PET/CT Scan
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Phase II Clinical Trial to Evaluate 18F-Fluoroestradiol Positron Emission Tomography / Computerized Tomography (PET/CT) Guided Fulvestrant Therapy for Patients With Recurrent or Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by British Columbia Cancer Agency:

Estimated Enrollment: 100
Intervention Details:
    Procedure: PET/CT Scan

    All subjects will be seen at baseline and then monthly till month 6 of fulvestrant therapy unless clinical or radiological progression or unacceptable toxicity earlier than month 6.

    During the study the subject will undergo the following scans:

    • A18F-FDG PET/CT scan performed at baseline, prior to starting the fulvestrant treatment, to identify the sites involved by the subject's cancer.
    • A 18F-FES PET/CT scan performed at baseline, prior to starting the fulvestrant treatment, to determine the hormone receptor content of the sites involved by the breast cancer.
    • A 18F-FES PET/CT scan performed after three (3) monthly injections of fulvestrant to determine whether estrogen uptake is blocked by fulvestrant.
Detailed Description:

The majority of women diagnosed with breast cancer are post-menopausal, of which up to 75% are estrogen (ER) and/or progesterone receptor (PR) positive. Even in pre-menopausal breast cancer over half of all patients will have expression of these hormone receptors. Thus therapeutic strategies targeting the estrogen receptor or its ligand are the most common treatment offered in breast cancer. Despite substantial benefits now demonstrated with selective estrogen receptor modulators (e.g. tamoxifen) and aromatase inhibitors (e.g. anastrazole, letrozole and exemestane), a significant proportion of patients will still unfortunately have or develop resistance to these hormonal therapies.

Despite approximately two-thirds of patients who are prescribed fulvestrant following prior hormonal agents not benefiting from this therapy, clinicians are still offering this option to all suitable women because of the lack of a better means of identifying the individual responders.

To assess whether the recommended treatment is beneficial to a specific individual, the disease burden is assessed before and following treatment. Conventional imaging techniques such as the bone scan or computerized tomography (CT) can take several months to show a successful response to treatment. Positron emission tomography (PET) can improve the evaluation of women with breast cancer by providing an accurate assessment of the extent of disease and unique information about tumor biology such as metabolic activity.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • post-menopausal (≥ 60 years old, or age ≥ 45 years with amenorrhea for > 12 months or follicle stimulating hormone and estrogen levels within post-menopausal range, or prior bilateral oophorectomy)
  • hormone receptor positive (ER and/or PgR) disease as determined locally
  • WHO performance status 0-2
  • life expectancy of ≥ 3 months
  • the presence of at least one measurable or evaluable (non-measurable) lesion
  • informed consent prior to any study procedures

Exclusion Criteria:

  • life threatening metastatic visceral disease
  • brain or leptomeningeal metastases
  • prior exposure to fulvestrant
  • history of bleeding diathesis or need for long term anti-coagulation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00816582

Contacts
Contact: Stephen Chia, MD 604-877-6000 ext 2752 schia@bccancer.bc.ca
Contact: Francois Benard, MD 604-877-6000 ext 5979 fbenard@bccancer.bc.ca

Locations
Canada, British Columbia
BC Cancer Agency - Southern Interior Not yet recruiting
Kelowna, British Columbia, Canada, V1Y 5L3
Contact: Susan Ellard, MD    250-712-3996    sellard@bccancer.bc.ca   
Principal Investigator: Susan Ellard, MD         
Sub-Investigator: Marianne Taylor, MD         
Sub-Investigator: Barbara Czerkawski, MD         
BC Cancer Agency - Fraser Valley Not yet recruiting
Surrey, British Columbia, Canada, V3V 1Z2
Contact: Gary Pansegrau, MD    604-930-4017    gpansegrau@bccancer.bc.ca   
Principal Investigator: Gary Pansegrau, MD         
Sub-Investigator: Abdulwahab Al-Tourah, MD         
Sub-Investigator: Ravinder Sawhney, MD         
BC Cancer Agency - Vancouver Centre Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Stephen Chia, MD    604-877-6000 ext 2752    schia@bccancer.bc.ca   
Contact: Francois Benard, MD    604-877-6000 ext 5979    fbenard@bccancer.bc.ca   
Principal Investigator: Stephen Chia, MD         
Sub-Investigator: Caroline Lohrisch, MD         
Sub-Investigator: Cheryl Ho, MD         
Sub-Investigator: Karen Gelmon, MD         
Sub-Investigator: Don Wilson, MD         
BC Cancer Agency - Vancouver Island Not yet recruiting
Victoria, British Columbia, Canada, V8R 6V5
Contact: Nicol Macpherson, MD    250-519-5572    nmacpherson@bccancer.bc.ca   
Sub-Investigator: Vanessa Bernstein, MD         
Principal Investigator: Nicol Macpherson, MD         
Sub-Investigator: Sheila Souliere, MD         
Sub-Investigator: Andrew Attwell, MD         
Sub-Investigator: Sharon Allan, MD         
Sub-Investigator: Jason Hart, MD         
Sponsors and Collaborators
British Columbia Cancer Agency
Investigators
Principal Investigator: Stephen Chia, MD BC Cancer Agency - Vancouver Centre
  More Information

No publications provided

Responsible Party: Dr Stephen Chia, British Columbia Cancer Agency - Vancouver Centre
ClinicalTrials.gov Identifier: NCT00816582     History of Changes
Other Study ID Numbers: PET/CT Breast, PET/CT, Recurrent or metastatic, Breast Cancer
Study First Received: December 30, 2008
Last Updated: September 2, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by British Columbia Cancer Agency:
post-menopausal hormone receptor positive recurrent/metastatic breast cancer.

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Fulvestrant
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014